Medical device package

ABSTRACT

A medical device package for receiving, and securely and removably retaining, a medical device includes main and minor cap members. The main cap member has a proximal end, a distal end and a cavity with a cavity opening at the proximal end. The cavity is configured to receive, and to securely and removably retain, the medical device at least partially therein. The minor cap member is configured to seal the cavity opening once the medical device has been received in the cavity.

CROSS-REFERENCE

This application is a continuation-in-part application of U.S.application Ser. No. 10/666,154, filed Sep. 19, 2003, which isincorporated herein by reference in its entirety and to whichapplication we claim priority under 35 USC § 120.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates, in general, to medical device packagesand, in particular, to medical device packages for receiving, andsecurely and removably retaining, a medical device.

2. Description of the Related Art

A variety of medical devices require packaging to, for example, protectthe medical device from damage prior to use and to maintain sterility ofthe medical device. For integrated medical devices that combine a dermaltissue penetration member (e.g., a lancet or micro-needle) with a teststrip, the associated package should provide for an uncomplicateddeployment of the dermal tissue penetration member during use, whilealso providing for protection of a user from inadvertent contact withthe dermal tissue penetration member prior and subsequent to use.Furthermore, the packaging should provide humidity resistance for thetest strip during storage.

Single-use (i.e., disposable) integrated medical devices areillustrative of the above requirements in that they require a medicaldevice package that maintains sterility and protects the single-useintegrated medical device contained therein from damage prior to use.Such medical device packages should also provide humidity resistance andUV protection for a test strip of such single-use integrated medicaldevices prior to use. Furthermore, the medical device package shouldprovide for deployment of a dermal tissue penetration member of such asingle-use integrated medical device during use, as well as fordisabling (i.e., preventing subsequent use) and safely discarding thesingle-use integrated medical device following use.

Conventional medical device packages do not fulfill all or even most ofthe requirements described above in a cost effective manner. Stillneeded in the field, therefore, is a medical device package thatprovides a sterility barrier and/or for protection of a medical deviceenclosed therein, while also providing for an uncomplicated deploymentof the medical device during use. Furthermore, for integrated medicaldevices that include a dermal tissue penetration member (e.g., a lancetor micro-needle), a need exists for a medical device package thatprotects the dermal tissue penetration member from damage, humidity,and/or contamination prior to use, that protects a user from accidentalcontact therewith and that also disables the medical device followinguse, thereby preventing its repeated use. In addition, the materials andmethods used to manufacture the medical device package should be costeffective.

SUMMARY OF THE INVENTION

Medical device packages according to the present invention provide asterility barrier and/or protection for a medical device (e.g., anintegrated medical device) enclosed therein. Embodiments of medicaldevice packages according to the present invention also provide for anuncomplicated deployment of the medical device during use. Furthermore,with respect to integrated medical devices that include a dermal tissuepenetration member (e.g., a lancet or micro-needle), medical devicepackages according to embodiments of the present invention protect thedermal tissue penetration member from damage, humidity, and/orcontamination prior to use, and protect a user from accidental contacttherewith. Embodiments of the medical device packages according to thepresent invention are also adapted to disable the medical devicefollowing use, thereby preventing its repeated use. In addition, due torelative simplicity of configuration, medical device packages accordingto the present invention are cost effective.

A medical device package according to embodiments of the presentinvention includes a main cap member and a minor cap member. The maincap member has a proximal end, a distal end and a cavity with a cavityopening at the proximal end. The cavity is configured to receive, and tosecurely and removably retain, a medical device (e.g., an integratedmedical device that includes a dermal tissue penetration member and atest strip) at least partially therein. The minor cap member isconfigured to seal the cavity opening once the medical device has beenreceived in the cavity.

Medical device package kits according to embodiments of the presentinvention include a main cap member, a minor cap member and a connector.The main cap member has a proximal end, a distal end and a cavity. Thecavity has a cavity opening at the proximal end of the main cap member.The cavity is configured to receive, and to securely and removablyretain, a medical device at least partially therein. The minor capmember is configured to seal the cavity opening once the medical devicehas been received in the cavity. The connector is configured to engagethe medical device during removal of the medical device from the cavity.

Methods according to the present invention enable the uncomplicateddeployment (i.e., extraction) of a medical device from a medical devicepackage. Methods for extracting a medical device from a medical devicepackage according to embodiments of the present invention first includeproviding a medical device package, with a medical device (e.g., anintegrated medical device) therein, and a connector. The providedmedical device package includes a main cap member having a cavity andproximal and distal ends, and a minor cap member. The cavity of the maincap member has a cavity opening at the proximal end of the main capmember and is configured to receive, and to securely and removablyretain, the medical device at least partially therein. The minor capmember is configured to seal the cavity opening.

The methods also include breaching the minor cap member with theconnector such that at least a portion of the connector enters thecavity. Next, the medical device is engaged by the connector andextracted from the medical device package.

Other methods according to the present invention include disabling amedical device that has been extracted from a medical device package byinserting the medical device back into a cavity of the medical devicepackage to a position that results in a disabling of repeated use of themedical device. Such disablement can be obtained by, for example, awedging of the medical device into a fixed position within the cavity ofthe medical device package.

BRIEF DESCRIPTION OF THE DRAWINGS

A better understanding of the features and advantages of the presentinvention will be obtained by reference to the following detaileddescription that sets forth illustrative embodiments, in which theprinciples of the invention are utilized, and the accompanying drawings(wherein like numerals represent like elements), of which:

FIG. 1 is a simplified exploded perspective view of a medical devicepackage according to the present invention;

FIGS. 2A-2D are simplified top, side, proximal end and perspectiveproximal end views of the main cap member of the medical device packageof FIG. 1;

FIG. 3A is a simplified cross-sectional side view of the main cap memberof the medical device package of FIGS. 1A through 2D, representing aview along line 3A-3A of FIG. 2A in the direction of the arrows;

FIG. 3B is a simplified cross-sectional top view of the main cap memberof the medical device package of FIGS. 1A through 2D, representing aview along line 3B-3B of FIG. 2C in the direction of the arrows;

FIGS. 4A and 4B are simplified perspective and side views, respectivelyof a medical device that can be contained within exemplary embodimentsof medical device packages according to the present invention;

FIG. 5A is a simplified proximal-end view of the main cap member of FIG.1, containing the medical device of FIGS. 4A and 4B, along with a legenddefining X and Z directions in the perspective of FIG. 5A;

FIG. 5B is a simplified cross-sectional view of the main cap member andmedical device of FIG. 5A, representing a view along line 5B-5B of FIG.5A in the direction of the arrows;

FIG. 5C is a cross-sectional, top view of the main cap member andmedical device of FIG. 5A, representing a view along line 5C-5C of FIG.5A in the direction of the arrows;

FIG. 5D is an enlargement of a portion of the cross-sectional, top viewof the main cap member and medical device of FIG. 5C;

FIGS. 6A and 6B are simplified top and perspective views of an exemplaryembodiment of a connector for use with exemplary embodiments of medicaldevice packages according to the present invention;

FIG. 6C is a side view of an exemplary embodiment of a connector,representing a view along line 6C-6C in FIG. 6A in the direction of thearrows;

FIG. 6D is a perspective view of the proximal end of an exemplaryembodiment of a connector that is used with the preferred embodiment ofthe medical device package according to the present invention;

FIG. 7 is a top view of a connector and a proximal end view of anexemplary embodiment of a medical device package according to thepresent invention;

FIG. 8 is a flow chart illustrating a sequence of steps in a process forextracting a medical device from a medical device package according toan exemplary embodiment of the present invention;

FIGS. 9A-D are schematic, cross-sectional views depicting various stagesof the process of FIG. 8;

FIGS. 10A-E are schematic, perspective views depicting various stages ofthe process of FIG. 8;

FIGS. 11A-C are schematic, top cross-sectional views depicting variousstages of the process of FIG. 8;

FIGS. 12A-C are schematic enlargements of portions of FIGS. 11A-C,respectively;

FIG. 13 is a flow chart illustrating a sequence of steps in a processfor extracting a medical device from a medical device package andsubsequently disabling the medical device according to an exemplaryembodiment of the present invention;

FIGS. 14A-D are schematic, cross-sectional views depicting variousstages of the process of FIG. 13;

FIGS. 15A-D are schematic, perspective views depicting various stages ofthe process of FIG. 13;

FIGS. 16A and 16B are schematic, top cross-sectional depictions of astage in the process of FIG. 13;

FIG. 17 is a simplified perspective view of a medical device packageaccording to another exemplary embodiment of the present inventioncontaining a medical device;

FIG. 18 is an exploded perspective view of yet another exemplaryembodiment of a medical device package containing an integrated medicaldevice according to the present invention;

FIG. 19 is an exploded perspective view of yet another exemplaryembodiment of a medical device package containing an integrated medicaldevice according to the present invention;

FIG. 20 is a simplified cross-sectional top view of an additionalexemplary embodiment of a medical device package according to thepresent invention;

FIG. 21 is a simplified cross-sectional top view of the medical devicepackage of FIG. 20 with a medical device retained therein;

FIG. 22 is a simplified cross-sectional top view of the medical devicepackage of FIG. 21 with a medical device disabled therein;

FIG. 23A is a simplified perspective view of a medical device packageaccording to another exemplary embodiment of the present invention witha medical device retained therein;

FIG. 23B is a simplified perspective proximal end view of the main capmember of the medical device package of FIG. 23A, representing a viewalong line 23B-23B of FIG. 23A in the direction of the arrows, alongwith a legend defining X and Z directions in the perspective of FIG. 23B

FIG. 24A is a simplified perspective view of a medical device packageaccording to yet another exemplary embodiment of the present inventionwith a medical device retained therein; and

FIG. 24B is a simplified perspective proximal end view of the main capmember of the medical device package of FIG. 24A, representing a viewalong line 24B-24B of FIG. 24A in the direction of the arrows, alongwith a legend defining X and Z directions in the perspective of FIG.24B.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1, 2A-2D, 3A and 3B are various simplified views of a medicaldevice package 100 according to an exemplary embodiment of the presentinvention. Medical device package 100 includes a main cap member 110 anda minor cap member 150.

Main cap member 110 includes a cavity 116 therein, a proximal end 112and a distal end 114. Cavity 116 has a cavity opening 118 at theproximal end 112 of the main cap member 110 and is configured toreceive, and to securely and removably retain, a medical device (e.g.,integrated medical device 300, illustrated in FIGS. 4A and 4B), at leastpartially therein.

FIGS. 4A and 4B are simplified perspective and side views, respectively,of an exemplary integrated medical device 300 that can be securely andremovably contained within medical device package 100. Integratedmedical device 300 includes a test strip 304 and a dermal tissuepenetration member 302, as illustrated in FIGS. 4A-4B. Test strip 304has a reaction area (not shown) and electrical contacts 306 thatterminate on a distal end 310 of integrated medical device 300.Electrical contacts 306 are made of any suitable conductive material,such as carbon. Dermal tissue penetration member 302 includes a lancet320 adapted to pierce a user's skin and draw blood into the reactionarea of test strip 304. Further descriptions of integrated medicaldevices that can be contained within embodiments of medical devicepackages according to the present invention are in InternationalApplication No. PCT/GB01/05634 (published as WO 02/49507 on Jun. 27,2002) and U.S. patent application Ser. No. 10/143,399, both of which arefully incorporated herein by reference. In addition, dermal tissuepenetration member 302 can be fabricated, for example, by a progressivedie-stamping technique, as disclosed in the aforementioned InternationalApplication No. PCT/GB01/05634 (published as WO 02/49507 on Jun. 27,2002) and U.S. patent application Ser. No. 10/143,399.

Referring again to FIGS. 1, 2A-2D, 3A and 3B, in the embodiment ofmedical device package 100, cavity opening 118 is bounded by a rim 120of sufficient surface area to enable minor cap member 150 to be adheredto rim 120 by processes known to those skilled in the art, including,but not limited to, heat sealing processes. In this manner, minor capmember 150 and main cap member 110 of medical device package 100 providea sterility barrier and humidity protection for a medical devicecontained therein.

External features of main cap member 110 include a first peripheral edge122, a second peripheral edge 124, a main cap upper surface 126 and amain cap lower surface 128. As shown in FIG. 2A, first peripheral edge122 and second peripheral edge 124 are truncated to end at the distaledge 121 of rim 120. If desired, the first and second peripheral edges122, 124 can be asymmetrically disposed about a longitudinal axis of themain cap member. Such an asymmetric configuration can serve to properlyorient the medical device package during its insertion into a receivingslot of associated hardware (for example, an analytical meter receivingslot configured to direct the medical device package to a connectordescribed below with respect to FIGS. 6A-6D).

As shown in FIGS. 1 and 2A, main cap upper surface 126 optionallyincludes a directional marker 130 that is discontinuous with (e.g.,raised above or, alternatively, recessed below) the remainder of maincap upper surface 126. Directional marker 130 may include, but is notlimited to, an ellipse 132 and an arrow 134, as depicted in FIGS. 1 and2A. Directional marker 130 provides a user with both tactile and visualcues for proper orientation of medical device package 100 during use.

Cavity 116 is defined (at least in part) by a first smooth inner surface127 and a second smooth inner surface 129 and includes first and secondlateral channels 140 and 142, respectively, as shown in FIGS. 2C-2D and3B. In addition, cavity 116 is also defined by first lateral surface 170located internally to first peripheral edge 122 and a second lateralsurface 172 located internally to second peripheral edge 124. In thevicinity of proximal end 112, first lateral surface 170 has a firstsloped land 160, and second lateral surface 172 has a second sloped land162. First sloped land 160 terminates at the beginning of first lateralchannel 140, while second sloped land 162 terminates at the beginning ofsecond lateral channel 142. First lateral channel 140 and second lateralchannel 142 extend about half way along first and second lateralssurfaces 170 and 172, respectively. First and second sloped lands 160,162 begin at cavity opening 118, and slope inwardly and distally towardsdistal end 114 of main cap member 110.

First and second lateral channels 140 and 142 begin at the end of firstand second sloped lands 160 and 162, respectively, and extendapproximately half way into cavity 116. First and second lateralchannels 140 and 142 are divided into a post-use portion 202, atransition point 204, and a pre-use portion 206 (see FIGS. 3A and 3B).As is evident from FIG. 3B, first lateral channel 140 is the mirrorimage of second lateral channel 142. One skilled in the art willrecognize from the entirety of the present disclosure that first andsecond sloped lands 160, 162, first and second lateral channels 140,142, transition point 204, and pre-use portion 206 are configured toreceive, and securely and removably retain, a medical device withincavity 116. In addition, post-use portion 202 is configured to disable aused medical device (as explained in detail below with respect to, forexample, FIGS. 16A and 16B).

Main cap member 110 can be formed of any suitable material known tothose of skill in the art including, for example, rigid plasticmaterials such as polystyrene, polycarbonate and polyester. Such rigidplastic materials are impervious to puncturing and to air and/orair-borne bacteria and, therefore, provide a sterility barrier and apuncture-resistant protective barrier. It can be particularly beneficialin terms of humidity protection for main cap member 110 to be formed ofa desiccant-loaded high-density polyethylene (e.g., 2AP desiccant-loadedhigh-density polyethylene, commercially available from Airsec inFrance).

Minor cap member 150 is configured to seal cavity opening 118 once amedical device has been received in cavity 116. In the embodiment ofFIG. 1, minor cap member 150 is a breachable film such as breachablemetallic foil. Other suitable materials for minor cap member 150 includepaper, polymer and Tyvek. However, as described with respect to otherembodiments below, minor cap member 150 can take a variety of forms, allof which are capable of sealing the cavity opening of an associated maincap member once a medical device has been at least partially receivedwithin the cavity of the main cap member.

FIG. 2D is a proximal end perspective view of main cap member 110.Transition point 204 includes a vertical shoulder 204A and a horizontalshoulder 204B, as shown in FIG. 2D. Upon insertion of an unused medicaldevice (e.g., integrated medical device 300 of FIGS. 4A and 4B prior touse) into cavity 116 of main cap member 110, vertical shoulder 204Aprevents the medical device (not shown) from being inserting pasttransition point 204 (see FIGS. 3A and 3B). In other words, the unusedmedical device is inserted only to a first position, which is defined bycontact of the unused medical device with transition point 204. However,once a medical device is used, such a used medical device can beinserted back into cavity 116 of main cap member 110 for disablement anddisposal purposes. In doing so, the used medical device (e.g.,integrated medical device 300 of FIGS. 4A and 4B subsequent to use) isinserted beyond the first position to a second position, wherein theused medical device extends past transition point 204 toward distal end114 and is irreparably damaged (i.e., disabled) by horizontal shoulder204B. Such damage prevents a subsequent removal, and thus repeated use,of the once used medical device.

FIGS. 5A-5D are various views of main cap member 100 of FIG. 1 withintegrated medical device 300 of FIGS. 4A and 4B inserted therein priorto use of integrated medical device 300 (i.e., integrated medical device300 is “unused”). In FIGS. 5A-5D, integrated medical device 300 extendsbetween first lateral channel 140 and second lateral channel 142 andlies parallel to first smooth inner surface 127 and second smooth innersurface 129. Unused integrated medical device 300 is securely retainedwithin cavity 116 via a friction fit with first lateral channel 140 andsecond lateral channel 142 such that integrated medical device 300 isengaged by first and second lateral channels 140 and 142 in at least onedirection (i.e., integrated medical device 300 is restrained from freemovement in at least one of the X and/or Z directions of FIG. 5A).Distal end 310 of integrated medical device 300 remains within proximalend 112 of medical device package 100 and is not in contact with firstlateral channel 140 and second lateral channel 142. Furthermore, itshould be noted that lancet 320 is within cavity 116 and thus protectedfrom inadvertent damage. Unused integrated medical device 300 ispositioned within first and second lateral channels 140 and 142 suchthat proximal end 312 of integrated medical device 300 touches, but goesno further than, transition point 204, and distal end 310 of integratedmedical device 300 remains free from contact with first and secondlateral channels 140 and 142 in cavity 116 (see FIGS. 5C and 5D) of maincap member 110.

FIGS. 6A through 6D depict an exemplary embodiment of a connector 500adapted to extract integrated medical device 300 from medical devicepackage 100. In addition, connector 500 can advantageously be used tomechanically and/or manually manipulate such a medical device once themedical device has been extracted from the medical device package. Forexample, connector 500 can be used to transfer a medical device from amedical device package to a metering system. As will be appreciated bythose skilled in the art, connector 500 may be a component (either aremovable component or a permanently integrated component) of a meteringsystem (e.g., an analytical meter configured to determine analyteconcentrations in biological fluid samples). Alternatively, connector500 can be combined with medical device packages to form a kit accordingto an exemplary embodiment of the present invention.

Connector 500 includes a strip extracting member 502 and a connectorbody 504. In addition, connector 500 includes a proximal end 510, adistal end 512, an upper surface 514 and a lower surface 516. Connectorbody 504 includes a connector directional marker 518 on upper surface514. Connector directional marker 518 (optional) is discontinuous with(e.g., raised above or recessed below) upper surface 514 of connector500. Connector directional marker 518 may include, but is not limitedto, an ellipse 530 and an arrow 532. Connector directional marker 518provides a user with both tactile and visual cues for proper orientationof connector 500 when inserted into medical device package 100.

Strip extracting member 502 includes a lower strip engaging arm 540, anupper strip engaging arm 542 and a plurality of strip engaging elements544, as illustrated in FIGS. 6C-6D. Connector 500 also includeselectrical leads (not shown) for providing an electrical connection(s)between strip engaging elements 544 and an analytical meter. Inaddition, strip extracting member 502 includes a vertical barrier 550that contacts distal end 310 of integrated medical device 300 whenintegrated medical device 300 is engaged by connector 500. Althoughthree strip engaging elements 544 are depicted in FIG. 6D for thepurpose of illustration and explanation, strip extracting member 502 caninclude any suitable number of strip-engaging elements. Strip engagingelements 544 are located on inner surface 543 of upper strip engagingarm 542. Strip engaging elements 544 are spring-loaded connectionsformed, for example, by being molded into connector 500 by any suitableprocess known to those skilled in the art. Strip engaging elements 544are used to contact test strip 304 of integrated medical device 300through electrical contacts 306. One skilled in the art will recognizethat connector 500 can provide electrical communication between teststrip 304 and an analytical meter via strip engaging elements 544 andthe connector's electrical leads.

FIG. 7 is a top view of connector 500 and a proximal end view of maincap member 110, with dashed vertical lines showing proper alignment ofconnector 500 during extraction of a medical device. Solids horizontalline 5F-5F indicates width of the medical device (for example,approximately 5.5 mm), while solid horizontal line 5G-5G indicates thewidth of strip extracting element 502 (for example, approximately 4.5mm).

FIG. 8 is a flow chart illustrating a sequence of steps in a process 800for extracting a medical device from a medical device package accordingto an exemplary embodiment of the present invention. Process 800 isdescribed below utilizing FIGS. 9A-D (schematic, cross-sectional viewsdepicting various stages of process 800), FIGS. 10A-E (schematic,perspective views depicting various stages of process 800), FIGS. 11A-C(schematic, top cross-sectional views of various stages of process 800)and FIGS. 12A-C (schematic enlargements of portions of FIGS. 11A-C,respectively).

Process 800 includes first providing (i) a medical device package with aminor cap member and a medical device contained therein and (ii) aconnector, as set forth in step 810 of FIG. 8. One skilled in the artwill recognize that the provided medical device package and connectorcan be any suitable medical device package according to the presentinvention that includes a breachable minor cap member (e.g., the medicaldevice package of FIG. 1) and any suitable connector according to thepresent invention. The provision of an exemplary medical device packageand connector are depicted in FIG. 9A and FIG. 10A, wherein likeelements of the medical device package and connector of earlier figuresare identified with like numerals.

Next, as set forth in step 820, the minor cap member is breached (e.g.,ruptured) with the connector such that at least a portion of theconnector has entered into the cavity of the main cap member (see FIG.9B, 10B, 11A and 12A). Subsequently, the medical device is engaged bythe connector (see FIGS. 9C, 11C, 11B and 12B), as set forth in step830. The force required for the connector to engage with the medicaldevice is, for example, approximately 2N. The connector and engagedmedical device are then extracted from the cavity of the medical devicepackage, as set forth in step 840 (see FIGS. 9D, 10D-10E, 11C and 12C).Each of the steps of process 800 can be performed, for example, eithermanually by a user or with the aid of a mechanical and/or electricaldevice.

It should be noted, that beaching the minor cap member (such as abreachable film) and engaging the medical device with the connector donot result in the medical device moving past the transition points 204of the first and second lateral channels 140, 142 (as depicted in FIGS.12A and 12B, which correspond to the breaching and engaging steps ofprocess 800) since the force required to move the medical device pasttransition points 204 (e.g., 7N) is significantly greater than the forcerequired to engage the connector with the medical device (e.g., 2N). Inthe embodiment of FIGS. 9A-9D, 10A-10E, 11A-11C and 12A-12C, during theengaging step, strip engaging elements of the connector engage a teststrip 304 of integrated medical device 300 and a vertical barrier of theconnector contacts the distal end of the integrated medical device 300.The force required for the breaching the minor cap member and engagementof the medical device can be, for example, in the range of about 1.5 Nto 2.5 N.

Solid line 5F-5F of FIG. 10E represents a dimension that is identical tothe dimension of solid horizontal line 5F-5F of FIG. 7 (i.e., the widthof integrated medical device 300). Solid line 10H-10H in FIG. 10Erepresents the width of the medical device's lancet. Solid line 10I-10Iof FIG. 10E represents the width of cavity opening of medical devicepackage, which is larger than the dimension represented by solid line5F-5F to assure a medical device's smooth insertion into, and removalfrom the cavity.

Process 800 can be performed manually or automatically. Furthermore,process 800 can be, for example, performed by an integrated device thatcombines an analytical meter and a connector in a configuration thatprovides for (i) a medical device to be extracted from a medical devicepackage; (ii) a sample (e.g., a whole blood sample) to be obtained froma user and (iii) an analytical result (e.g., blood glucose concentrationof the whole blood sample) to determined, all by a single operation ofthe integrated device. Mechanical motions may be incorporated into alancet cocking action, new test strip deployment and/or ejection.

FIG. 13 is a flow chart illustrating a sequence of steps in a process1300 for extracting a medical device from a medical device package foruse and subsequently disabling the medical device after use according toan exemplary embodiment of the present invention. Process 1300 isdescribed below utilizing FIGS. 14A-14D (schematic, cross-sectionalviews depicting various stages of process 1300), FIGS. 15A-15D(schematic, perspective views depicting various stages of process 1300)and FIGS. 16A-16B (schematic, top cross-sectional views of a stage ofprocess 1300).

Process 1300 includes first providing (i) a medical device package witha minor cap member and a medical device contained therein at a firstposition and (ii) a connector, as set forth in step 1310 of FIG. 13. Oneskilled in the art will recognize that the provided medical devicepackage and connector can be any medical device package according to thepresent invention that includes a breachable minor cap member (e.g., themedical device package of FIG. 1).

Next, at step 1320, the minor cap member is breached (e.g., ruptured)with the connector such that at least a portion of the connector hasentered the cavity of the main cap member. The medical device is thenengaged by the connector, as set forth in step 1330. The connector andengaged medical device are then extracted from the cavity of the medicaldevice package for use, as set forth in step 1340.

Subsequently, at step 1350, the connector and engaged medical device areinserted back into a cavity of the medical device package to a secondposition, whereby the medical device is disabled from reuse (see FIGS.14A-14C, 15A-15C and 16A-16B). The connector is then disengaged from themedical device and withdrawn from the medical device package, as setforth in step 1360. It is envisioned that during step 1350, the medicaldevice is disabled by virtue of the medical device being wedged into thecavity such that the force required to remove the medical device fromthe cavity is greater than the force required to disengage the connectorfrom the medical device. Therefore, an attempt to re-extract the medicaldevice with the connector would be unsuccessful since the connectorwould become disengaged from the medical device before sufficient forcecould be applied to extract the wedged medical device.

It should be noted that during insertion of the connector and engagedmedical device into the cavity at step 1350, the medical device isinserted to a second position within post-use portion 202 that is beyondtransition points 204 of the first and second lateral channels (see, inparticular, FIG. 16B), i.e., beyond the first position. The forcerequired to insert the medical device into the medical device packageand disable the medical device is, for example, approximately 7N. Asnoted above, disablement of the medical device is a result of themedical device being wedged into the cavity such that it cannot bere-extracted using the connector.

FIG. 17 depicts a medical device package 1900 according to anotherexemplary embodiment of the present invention. In FIG. 17, dashed linesindicate certain features that are hidden due to the perspective natureof FIG. 17. In addition, FIG. 17 depicts the circumstance where amedical device (i.e., integrated medical device 300 of FIGS. 4A and 4B)is retained partially within medical device package 1900. In theembodiment of FIG. 17, electrical contacts 306 project from the cavityopening and minor cap member. Since electrical contacts 306 project fromboth the cavity opening and the minor cap member, engagement of theelectrical contacts with a connector can be simplified. For example,there is no need to breach or otherwise remove any component of themedical device package to obtain access to the electrical contacts andthe electrical contacts are free to deflect upon engagement with aconnector.

Medical device package 1900 includes a main cap member 1910 with aproximal end 1912, a distal end 1914, a cavity 1918 and a cavity opening1916. Distal end 1914 is configured to function as a handle duringmanually removal of medical device package 1900 from secondary packaging(not illustrated).

Medical device package 1900 can be constructed, for example, of moldedplastic or other material that is impervious to air and/or air-bornebacteria, to provide a sterile-protective and puncture-resistantbarrier. Suitable materials include, but are not limited to,polystyrene, polyethylene, polycarbonate and polyester.

Cavity 1918 of medical device package 1900 is defined by surfacesdepicted with dashed lines in FIG. 17. Cavity opening 1916 is configuredto provide for the placement of dermal tissue penetration member 302 ofintegrated medical device 300 wholly within cavity 1918, as shown inFIG. 17. Medical device package 1900 includes internally disposed ribs1960, located distally to cavity opening 1916. Ribs 1960 serve to sealcavity 1918 once a medical device has been inserted partially therein,and provide a sterile and protective barrier for dermal tissuepenetration member 302 by creating a tortuous path between the externalenvironment and the cavity of the medical device package. Ribs 1960,together with an at least partially inserted medical device, serve as aminor cap member for medical device package 1900. As an alternative toribs 1960, elastomeric o-rings could be employed to seal cavity 1918once a medical device has been inserted partially therein, and toprovide a sterile and protective barrier for dermal tissue penetrationmember 302.

FIG. 18 is an exploded perspective view of a medical device package 2000according to yet another exemplary embodiment of the present inventioncontaining a integrated medical device 300 (as depicted in FIGS. 4A and4B). Medical device package 2000 includes a main cap member 2010 and aminor cap member 2020. Main cap member 2010 has a proximal end 2012, adistal end 2014, a cavity opening (not shown), and a cavity (also notshown). The cavity and cavity opening of main cap member 2010 areconfigured for placement of a dermal tissue penetration member of anintegrated medical device wholly therein, thus providing a protectivebarrier for such a dermal tissue penetration member.

Minor cap member 2020 has a proximal end 2022, a distal end 2024, aminor cap opening 2026, and a minor cap cavity (not shown in FIG. 18).Minor cap opening 2026 and the minor cap cavity are configured for theplacement of a test strip 304 of an integrated medical device wholly orpartially therein. Furthermore, proximal end 2012 of main cap member2010 is adapted to fit wholly within minor cap opening 2026 and theminor cap cavity. Once main cap member 2010 is fit within minor capopening 2026 and the minor cap cavity, integrated medical device 300 iscompletely enclosed and provided with a sterile-protective andmoisture-free barrier.

Both main cap member 2010 and minor cap member 2020 are beneficiallyconstructed of molded plastic or other rigid material that is imperviousto air and/or air-borne bacteria, to provide a sterile-protective andpuncture-resistant barrier. Suitable materials for main cap member 2010and minor cap member 2020 include, but are not limited to, polystyrene,polyethylene, polycarbonate and polyester.

FIG. 19 is an exploded perspective view of a medical device package 2100according to yet another exemplary embodiment of the present invention.Medical device package 2100 includes a main cap member 2110 and a minorcap member 2120. Main cap member 2110 has a proximal end 2112, a distalend 2114, a cavity opening 2116 and a cavity (not shown). Cavity opening2116 and the cavity of medical device package 2100 are configured forplacement of a dermal tissue penetration member 302 of an integratedmedical device and a minor cap member proximal end 2122 (describedbelow) wholly therein, thus providing a protective barrier for dermaltissue penetration member 302.

Minor cap member 2120 of medical device package 2100 has a proximal end2122 and a distal end 2124. Moreover, integrated medical device 300 ispermanently attached to minor cap member 2120 at proximal end 2122. Thepermanent attachment of such an integrated medical device to minor capmember 2120 is envisioned to provide handling benefits during use of theintegrated medical device. For example, minor cap member 2120 could begripped by a meter, with the main cap member then being easily removedby a user (e.g., by pulling, twisting or snapping) to deploy theintegrated medical device.

FIGS. 20, 21 and 22 depict the main cap member 2450 of a medical packagedevice according to yet another exemplary embodiment of the presentinvention (for purposes of clarity, the minor cap member of this medicaldevice package is not illustrated). FIG. 21 depicts an integratedmedical device 300 retained within main cap member 2450 and FIG. 22depicts an integrated medical device 300 disabled within main cap member2450. Main cap member 2450 is identical to main cap member 110 of FIG.3B, with the exception that main cap member 2450 has a distal end cavity2452 configured for disablement and disposal of an integrated medicaldevice.

FIGS. 23A and 23B are simplified views of a medical device package 2500according to another exemplary embodiment of the present invention withan integrated medical device 300 (as depicted in FIGS. 4A and 4B)retained therein. In FIG. 23A, dashed lines indicate certain featuresthat are hidden from view due to the perspective nature of FIG. 23A.

Referring to FIGS. 23A and 23B, medical device package 2500 includes amain cap member 2510 and a minor cap member 2520 (see FIG. 23A). Maincap member 2510 has a proximal end 2512, a distal end 2514, a cavityopening 2516, and a cavity 2518. Cavity 2518 and cavity opening 2516 ofmain cap member 2510 are configured for placement of a dermal tissuepenetration member of an integrated medical device wholly therein, thusproviding a protective barrier for such a dermal tissue penetrationmember.

Cavity opening 2516 is bounded by rim 2522 of Main cap member 2510. Rim2533 is configured to mate with surface 2523 of minor cap member 2520.In FIG. 23A, minor cap member 2520 is depicted as a cap that ispermanently attached to main cap member 2510 by flexible minor capmember portion 2520′. Flexible minor cap member portion 2520′ isconfigured such that the minor cap member can be position to closecavity opening 2516 (for example, by snap fitting of minor cap member2520 onto proximal end 2512 of main cap member 2510. However, it isnoted that minor cap member can also be a foil seal that is adhered torim 2522 by processes known to those skilled in the art, including, butnot limited to, heat sealing processes. In this manner, minor cap member2520 and main cap member 2510 of medical device package 2500 provide asterility barrier and humidity protection for a medical device containedtherein.

Both main cap member 2510 and minor cap member 2520 (other than flexibleminor cap member portion 2520′) are beneficially constructed of moldedplastic or other rigid material that is impervious to air and/orair-borne bacteria, to provide a sterile-protective andpuncture-resistant barrier. Suitable materials for main cap member 2510and minor cap member 2520 include, but are not limited to, polystyrene,polyethylene, polycarbonate and polyester.

Cavity 2518 is defined (at least in part) by a first smooth innersurface 2524 and a second smooth inner surface 2526 and includes firstand second lateral channels 2528 and 2530, respectively, as shown inFIG. 23B. In addition, cavity 2518 is also defined by first lateralsurface 2532 and a second lateral surface 2534. In FIG. 23B, firstlateral channel 2528 and second lateral channel 2530 extend along aboutthe middle third of first and second lateral surfaces 2532 and 2534,respectively. However, once apprised of the present disclosure, oneskilled in the art will recognize that first and second lateral channels2528 and 2530 can also extend along the entire first and second lateralsurfaces 2532 and 2534, respectively, or along any suitable portion offirst lateral surface 2532 and second lateral surface 2534.

Integrated medical device 300 extends between first lateral channel 2528and second lateral channel 2530 and lies parallel to first smooth innersurface 2524 and second smooth inner surface 2526. Unused integratedmedical device 300 is securely retained within cavity 2518 via afriction fit with first lateral channel 2528 and second lateral channel2530 such that integrated medical device 300 is engaged by first andsecond lateral channels 2528 and 2530 in at least one direction (i.e.,is restrained in the X and/or Z direction of FIG. 23B). The X and Zdirections of FIG. 23B are perpendicular to a longitudinal axis of firstand second lateral channels 2528 and 2530. Therefore, first and secondlateral channels 2528 and 2530, respectively, serve to restrain the freemovement of integrated medical device 300 in at least one directionperpendicular to the longitudinal axis of the lateral channels

Distal end 310 of integrated medical device 300 is within proximal end2512 of medical device package 2500 and is not in contact with firstlateral channel 2528 and second lateral channel 2530. Furthermore, itshould be noted that lancet 320 is within cavity 2518 and thus protectedfrom inadvertent damage.

FIGS. 24A and 24B are simplified views of a medical device package 2600according to yet another exemplary embodiment of the present inventionwith an integrated medical device 300 (as depicted in FIGS. 4A and 4B)retained therein. In FIG. 24A, dashed lines indicate certain featuresthat are hidden from view due to the perspective nature of FIG. 24A.

Medical device package 2600 includes a main cap member 2610 and a minorcap member (not shown). Main cap member 2610 has a proximal end 2612, adistal end 2614, a cavity opening 2616, and a cavity 2618. Cavity 2618and cavity opening 2616 of main cap member 2610 are configured forplacement of a dermal tissue penetration member of an integrated medicaldevice wholly therein, thus providing a protective barrier for such adermal tissue penetration member. Although the minor cap member ofmedical device package 2600 is not shown, it is configured to covercavity opening 2616 in a removable manner.

Cavity opening 2616 includes a rim 2622 of sufficient surface area toenable the minor cap member to be adhered to rim 2622 by processes knownto those skilled in the art, including, but not limited to, heat sealingprocesses. In this manner, minor cap member and main cap member 2610 ofmedical device package 2600 provide a sterility barrier and humidityprotection for a medical device contained therein.

Main cap member 2610 is beneficially constructed of molded plastic orother rigid material that is impervious to air and/or air-bornebacteria, to provide a sterile-protective and puncture-resistantbarrier. Suitable materials for main cap member 2610 include, but arenot limited to, polystyrene, polyethylene, polycarbonate and polyester.

Cavity 2618 is defined (at least in part) by a first smooth innersurface 2624 and a second smooth inner surface 2626 and includes firstand second lateral channels 2628 and 2630, respectively, as shown inFIG. 24B. In addition, cavity 2618 is also defined by first lateralsurface 2632 and a second lateral surface 2534. First lateral channel2628 and second lateral channel 2630 extend along approximately theentire first and second lateral surfaces 2632 and 2634, respectively.

Integrated medical device 300 extends between first lateral channel 2628and second lateral channel 2630 and lies parallel to first smooth innersurface 2624 and second smooth inner surface 2626. Unused integratedmedical device 300 is securely retained within cavity 2618 via afriction fit with first lateral channel 2628 and second lateral channel2630 such that integrated medical device 300 is engaged by first andsecond lateral channels 2628 and 2630 in at least one direction (i.e.,in the X and/or Z direction of FIG. 24B). Distal end 310 of integratedmedical device 300 remains within proximal end 2612 of medical devicepackage 2600 and is not in contact with first lateral channel 2628 andsecond lateral channel 2630. Furthermore, it should be noted that lancet320 is within cavity 2618 and thus protected from inadvertent damage.

Those skilled in the art will recognize that embodiments of medicaldevice packages according to the present invention can be secondarilypackaged for single use in, for example, a vial or cartridge configuredfor dispensing the medical device packages. The secondary package may beconstructed of material containing desiccant or may contain separatelypackaged desiccant for maintaining contents moisture free. Moreover,functional characteristics of the various embodiments of medical devicepackages (e.g., restraint of a medical device in an X or Z direction byat least one lateral channel) can be employed, if desired, in methodsaccording to the present invention.

Once apprised of the present disclosure, one skilled in the art willalso recognize that a variety of medical devices can be beneficiallyemployed with embodiments of medical device packages according to thepresent invention. Such medical devices include, but are not limited to,integrated medical devices that include a combination of a test stripand a lancet, examples of which are described in the aforementionedInternational Application No. PCT/GB01/05634 (published as WO 02/49507on Jun. 27, 2002) and U.S. patent application Ser. No. 10/143,399, bothof which are fully incorporated herein by reference. One skilled in theart will also recognize that such test strips may have, but are notlimited to, an electrochemical or photometric configuration. Forillustrative purposes only, medical devices in various figures of thepresent disclosure were depicted as having an electrochemicalconfiguration.

Moreover, those skilled in the art will appreciate that medical devicepackages according to embodiments of the present invention can beemployed with medical device adapted for the measurement of, forexample, glucose, ketones, glycated albumin, coagulation parameters andcholesterol of a sample.

In addition, one skilled in the art will also recognize that medicaldevice packages according to the present invention may be containedwithin a combined sample collection and metering system designed forin-situ testing. Examples of such systems designed for in-situ testingare disclosed in International Patent Application No. PCT/US01/07169(published as WO 01/64105 A1 on Sep. 7, 2001) and International PatentApplication No. PCT/GB02/03772 (published as WO 03/015627 A1 on Feb. 27,2003), each of which is fully incorporated herein by reference.

It should be understood that various alternatives to the embodiments ofthe invention described herein may be employed in practicing theinvention. It is intended that the following claims define the scope ofthe invention and that methods and structures within the scope of theseclaims and their equivalents be covered thereby.

1. A medical device package comprising: a main cap member with a cavitytherein, the main cap member including: a proximal end; and a distalend; and a minor cap member, wherein: the cavity has a cavity opening atthe proximal end of the main cap member; the cavity is configured toreceive, and to securely and removably retain, a medical device at leastpartially therein, the minor cap member is configured to seal the cavityopening once the medical device has been received in the cavity, and themain cap member includes at least one lateral channel and wherein themedical device is securely and removably retained by a friction fitbetween the medical device and the at least one lateral channel.
 2. Themedical device package of claim 1, wherein the at least one lateralchannel has a longitudinal axis and the at least one lateral channelrestrains free movement of the medical device package in at least onedirection perpendicular to the longitudinal axis.
 3. The medical devicepackage of claim 1, wherein the main cap member includes a directionalmarker.
 4. The medical device package of claim 1, wherein the main capmember cavity is configured to receive, and to securely and removablyretain, an integrated medical device that includes electrical contactssuch that the electrical contacts project from the cavity opening andminor cap member.
 5. The medical device package of claim 1, wherein theminor cap member includes ribs that seal the cavity opening.
 6. Themedical device package of claim 1, wherein the minor cap member is abreachable minor cap member.
 7. The medical device package of claim 1,wherein the minor cap member is configured for permanent attachment tothe medical device.
 8. The medical device package of claim 1, whereinthe main cap member further includes a distal end cavity configured fordisabling the medical device.